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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03160989
Other study ID # CEP UFU 002095/
Secondary ID
Status Completed
Phase N/A
First received May 3, 2017
Last updated May 19, 2017
Start date May 2016
Est. completion date December 2016

Study information

Verified date May 2017
Source Federal University of Uberlandia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will evaluate the variability of blood pressure in postmenopausal and hypertensive women after only one session and after training of ten weeks of combined physical exercises (aerobic and resisted).


Description:

Before starting the training program, all the volunteers will sign the Free and Informed Consent Form (TCLE) and must present a medical certificate releasing the participation. In addition, the volunteers will respond to an anamnesis questionnaire and will undergo an anthropometric evaluation before the experimental sessions. The physical exercise program will be held three times a week for 10 weeks, containing aerobic exercise (exercise treadmill) and resistance exercises (bodybuilding). Initially, a familiarization of the ergometers used will be performed, followed by a session to evaluate the intensity of resistance exercise through a maximal repetition test (1RM), and a session to evaluate aerobic fitness through an incremental treadmill test.

Before starting the training, volunteers will perform a single exercise session, following the same exercise protocol. All the volunteers will be submitted to the evaluation of the blood pressure during 24 hours through the measurement of ambulatory blood pressure (ABPM) in three moments:

- PR: pre-training rest - the volunteers will arrive at the laboratory, will be in rest for 15 minutes and after that they will place the ABPM, without having done any exercise.

- PE: post exercise - upon arriving at the laboratory, the volunteers will be submitted to a single combined exercise session, will have a maximum interval of 20 minutes for the bath and will place the MAP device.

- CR: rest after chronic training - after the end of the 10 weeks of training, the volunteers will be submitted to ABPM, again at rest, with a maximum interval of 72 hours, between the end of the training and the placement of the device.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date December 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria:

- Women aged between 50 and 70 years;

- Be in the postmenopausal phase;

- Be able to practice physical exercise on treadmill and resistance exercises (bodybuilding).

- Present stage 1 hypertension, according to the guidelines of the Brazilian Society of Hypertension

- Make use of anti-hypertensive medication, except beta-blockers

- Participants should be evaluated with a cardiologist beforehand and present a certificate attesting that they are able to perform physical activities.

- Do not present physical problems or cardiovascular complications that prevent the performance of physical exercises.

Exclusion Criteria:

- Make use of beta-blockers

- Present history of stroke or acute myocardial infarction;

- Smoking;

- Present diagnosis of Diabetes Mellitus.

- Present renal pathologies

- Use hormone replacement therapies

Study Design


Related Conditions & MeSH terms


Intervention

Other:
physical exercises
The intervention will consist of a single session and after ten weeks of combined physical exercises (aerobic and resisted). All volunteers will participate in the same procedure.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Uberlandia

References & Publications (3)

Coylewright M, Reckelhoff JF, Ouyang P. Menopause and hypertension: an age-old debate. Hypertension. 2008 Apr;51(4):952-9. doi: 10.1161/HYPERTENSIONAHA.107.105742. Epub 2008 Feb 7. Review. — View Citation

Gomes Anunciação P, Doederlein Polito M. A review on post-exercise hypotension in hypertensive individuals. Arq Bras Cardiol. 2011 May;96(5):e100-109. Epub 2011 Mar 4. Review. English, Portuguese, Spanish. — View Citation

Puga GM, Kokubun E, Simões HG, Nakamura FY, Campbell CS. Aerobic fitness evaluation during walking tests identifies the maximal lactate steady state. ScientificWorldJournal. 2012;2012:769431. doi: 10.1100/2012/769431. Epub 2012 May 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in ambulatory blood pressure variability in ten weeks The ambulatory blood pressure measurement will be performed for 24 hours. With the information obtained in this measurement, blood pressure variability will be performed. After ten weeks and before ten weeks of exercise training
Secondary Comparison resting blood pressure The resting blood pressure is performed after 15 minutes of sitting, measured three times and the mean is calculated for analysis After ten weeks and before ten weeks of exercise training
Secondary Anthropometric assessments Body composition of the volunteers After ten weeks and before ten weeks of exercise training
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